BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3945039 · Received July 18, 2014

    Report

    Report Number
    3004209178-2014-87773
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY EXPERIENCED VERY LOW BLOOD GLUCOSE DURING THEIR FLIGHT. WHEN THEY BOARDED THE BLOOD GLUCOSE WAS 167 MG/DL AND TWO HOURS LATER IT DECREASED TO 37 MG/DL WHICH WAS TREATED WITH A DRINK. THE CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF THE PHONE CALL WAS 37 MG/DL. THE CUSTOMER STATED THAT THEY HAVE BEEN EXPERIENCING LOW BLOOD GLUCOSE FOR A FEW MONTHS. THE DRIVE SUPPORT CAP WAS RECESSED. THE CUSTOMER WAS NOT DISCONNECTED DURING THE REWIND/PRIME SEQUENCE. THE TIME WAS INCORRECT DUE TO THE TIME ZONE CHANGE. SHE WAS ADVISED TO ADJUST THE TIME FOR THE DURATION OF THE TRIP IN THE EAST COAST. THE CUSTOMER STATED THAT THEY WERE AT THE END OF SCHOOL AND WERE UNDER MORE STRESS. THE DEVICE WAS NOT EXPOSED TO A STRONG MAGNETIC FIELD OR MRI BUT, THE CUSTOMER WENT THROUGH A FULL BODY SCAN. THE DISPLACEMENT TEST PASSED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421754 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR